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Suprascapular Notch Cross-sectional Area Measured by Ultrasonography

Primary Purpose

Shoulder Pain, Shoulder Impingement Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ultrasound
Sponsored by
Bursa Yüksek İhtisas Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Shoulder Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: chronic shoulder pain 35-65 years who agreed to participate in the study Exclusion Criteria: . Lymphoproliferative diseases and other neoplasms .Uncontrolled arterial hypertension Metabolic syndrome Uncontrolled diabetes mellitus Mental retardation Antidepressant use Autoimmune diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    diseased shoulder

    sturdy shoulder

    Arm Description

    Outcomes

    Primary Outcome Measures

    Suprascapular notch cross-sectional area measurement
    The area under the suprascapular notch and the superior transverse scapular ligament is measured using the cross-sectional area measurement method.

    Secondary Outcome Measures

    Visual Analogue Scale
    Visual Analog Scale was used for pain. Pain intensity was measured using 0-10 cm visual analogue scale (VAS). The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.
    Shoulder Pain and Disability Index (SPADI)
    The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with activity of daily livings requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items.To score either version of the SPADI, the total score is calculated by averaging the pain and disability subscale scores to find a score out of 100. On this scale, 0 represents less disability while 100 represents greatest disability

    Full Information

    First Posted
    August 4, 2023
    Last Updated
    August 17, 2023
    Sponsor
    Bursa Yüksek İhtisas Education and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05996510
    Brief Title
    Suprascapular Notch Cross-sectional Area Measured by Ultrasonography
    Official Title
    Investigation of the Relationship Between Suprascapular Notch Cross-sectional Area Measured by Ultrasonography and Disease Activity in Subacromial Impingement Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 10, 2023 (Anticipated)
    Primary Completion Date
    October 10, 2023 (Anticipated)
    Study Completion Date
    October 11, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bursa Yüksek İhtisas Education and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Chronic shoulder pain is one of the most common diseases affecting the quality of life today. Although there are multiple causes, one of the most common causes is shoulder impingement syndrome. Ultrasound can be used for diagnosis in patients whose treatment is difficult due to its complex structure. While the supraspinatus muscle, tendon and shoulder joint are the regions that are usually evaluated, the visualization of the Suprascapular notch is usually observed during injection. The connection between the suprascapular notch and the shoulder joint has been demonstrated in different studies.
    Detailed Description
    In this study, the investigation of the relationship between the measurements of the suprascapular nerve and the suprascapular notch, which the investigators observed in our clinical ultrasound applications, and the disease activity intended.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shoulder Pain, Shoulder Impingement Syndrome

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    diseased shoulder
    Arm Type
    Active Comparator
    Arm Title
    sturdy shoulder
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    ultrasound
    Other Intervention Name(s)
    shoulder ultrasound
    Intervention Description
    Shoulder ultrasound is performed using a linear ultrasound probe. The area under the suprascapular notch and the superior transverse scapular ligament is measured using the cross-sectional area measurement method.
    Primary Outcome Measure Information:
    Title
    Suprascapular notch cross-sectional area measurement
    Description
    The area under the suprascapular notch and the superior transverse scapular ligament is measured using the cross-sectional area measurement method.
    Time Frame
    baseline
    Secondary Outcome Measure Information:
    Title
    Visual Analogue Scale
    Description
    Visual Analog Scale was used for pain. Pain intensity was measured using 0-10 cm visual analogue scale (VAS). The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.
    Time Frame
    baseline
    Title
    Shoulder Pain and Disability Index (SPADI)
    Description
    The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with activity of daily livings requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items.To score either version of the SPADI, the total score is calculated by averaging the pain and disability subscale scores to find a score out of 100. On this scale, 0 represents less disability while 100 represents greatest disability
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: chronic shoulder pain 35-65 years who agreed to participate in the study Exclusion Criteria: . Lymphoproliferative diseases and other neoplasms .Uncontrolled arterial hypertension Metabolic syndrome Uncontrolled diabetes mellitus Mental retardation Antidepressant use Autoimmune diseases
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Burcu Ökmen, Assoc.Phd.MD
    Phone
    +905057081020
    Email
    burcumetinokmen@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    korgün ökmen
    Organizational Affiliation
    Bursa Yuksek Ihtisas Training and Research Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Lale altan inceoğlu, phd
    Organizational Affiliation
    uludağ university faculty of medicine
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    ugur ertem, M.D.
    Organizational Affiliation
    uludağ university faculty of medicine
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Suprascapular Notch Cross-sectional Area Measured by Ultrasonography

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